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NCT06403683 Clinical Trial

Physical Activity Level and Insomnia

Primary Dysmenorrhea Clinical Trial

Official title:
Relationship Between Physical Activity Levels and Insomnia in Females With Primary Dysmenorrhea

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06403683
Other study ID # P.T.REC/012/004951
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 30, 2024
Est. completion date May 15, 2024

Study information
Verified date May 2024
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study aims to investigate the relationship between physical activity levels and insomnia in females with primary dysmenorrhea.

Description:

This study will be designed as a case-control study, conducted on 150 females recruited from El_Nassr hospital in Helwan, Cairo, Egypt and from social media. Patients will be divided into two equal groups: group A(75 patients complain from PD according to WaLIDD score)& group B(75 patients don't complain from PD according to WaLIDD score). All data and information of each female in this study, including name, age, address, weight, height, and menstrual history, will be recorded in a recording data sheet. WaLIDD score will be used to assess PD symptoms, Insomnia Severity Index will be used to assess insomnia, International Physical Activity Questionnaire (Short-form)& Six-Minute Walk Test will be used to assess physical activity levels. Inclusion criteria: 1)Patient ages will be ranged between 18-25 years old, 2)They do not receive any drugs, 3)Being a virgin. Participants will be excluded if they 1) Using hormonal contraception (such as oral contraceptives and injections), 2)Taking any medications, 3)History of chronic disease, 4)Having any psychiatric or gynecological problems (such as PCO, amenorrhea, women who suffered from menopause). The subject, who missed for any of assessment session, would be withdraw form the research.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 150
Est. completion date May 15, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: 1. Patient ages will be ranged between 18-25 years old. 2. They do not receive any drugs. 3. Being a virgin . Exclusion Criteria: 1. Using hormonal contraception (such as oral contraceptives and injections). 2. Taking any medications. 3. History of chronic disease. 4. Having any psychiatric or gynecological problems (such as PCO, amenorrhea, women who suffered from menopause).

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• WaLIDD score / Insomnia Severity Index (ISI) / International Physical Activity Questionnaire (Short-form) / Six-Minute Walk Test
Case control trial study

Locations
Country Name City State
Egypt Cairo University Giza

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Insomnia Record insomnia severity during menstruation Through study completion, an average of 6 months
Primary Physical activity level Record Physical activity level during menstruation Through study completion, an average of 6 months
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